International Journal of TROPICAL DISEASE & Health, ISSN: 2278-1005,Vol.: 29, Issue.: 1
Efinaconazole 10% Topical Solution: Treatment of Mild to Moderate Toenail Onychomycosis in Japanese Subjects
Theodore Rosen1* and Tina Lin2 1Department of Dermatology at Baylor College of Medicine, Houston, Texas, USA. 2Valeant Pharmaceuticals North America LLC., Bridgewater, New Jersey, USA.
Theodore Rosen1* and Tina Lin2
1Department of Dermatology at Baylor College of Medicine, Houston, Texas, USA.
2Valeant Pharmaceuticals North America LLC., Bridgewater, New Jersey, USA.
(1) Jorge Paredes Vieyra, Universidad Autonoma De Baja California, Campus Tijuana, Mexico.
(1) Shari Lipner, Weill Cornell Medicine, USA.
(2) K. R. Raghavendra, Mysore Medical College and Research Institute, India.
Complete Peer review History: http://www.sciencedomain.org/review-history/23157
Objective: To evaluate efficacy, safety, and tolerability of efinaconazole topical solution, 10% in a cohort of Japanese patients with mild to moderate toenail onychomycosis.
Methods: A subgroup analysis of patients, aged 22-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from a multicenter, double-blind, vehicle-controlled 48-week study evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at Week 52.
Results: The primary end point, complete cure, was achieved in 30.6% of patients treated with efinaconazole compared to 12.3% with vehicle (Observed case, P=.006), and was significantly better than that seen in the non-Japanese patients (P<.001). Treatment success (percent affected target toenail ≤10% at week 52) for efinaconazole was 60.6% compared to 33.3% with vehicle (P<.001). The majority of adverse events (AEs) were mild (16.6%) or moderate (81.1%) and few (7.8%) associated with efinaconazole. Eleven patients (6.0%) treated with efinaconazole discontinued the study due to AEs.
Conclusions: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of mild to moderate onychomycosis among ethnic Japanese patients.
Efinaconazole; onychomycosis; japanese subjects.
DOI : 10.9734/IJTDH/2018/36283Review History Comments